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    Clinical Trial Results:
    Immunogenicity and Safety of Multiple Formulations of an Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With and Without Adjuvant in Healthy European Subjects Aged 6 to 35 Months

    Summary
    EudraCT number
    2009-013858-32
    Trial protocol
    FI  
    Global end of trial date
    05 Jan 2011

    Results information
    Results version number
    v1(current)
    This version publication date
    16 Feb 2016
    First version publication date
    29 Jan 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GPF09
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00956046
    WHO universal trial number (UTN)
    U1111-1111-5029
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    2, avenue Pont Pasteur, Lyon cedex 07, France, F-69367
    Public contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 4 37 37 58 50, stephanie.pepin@sanofipasteur.com
    Scientific contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 4 37 37 58 50, stephanie.pepin@sanofipasteur.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Apr 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Jan 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To describe the immune response of each candidate vaccine 21 days after each vaccination by hemagglutination inhibition (HAI) and seroneutralization (SN) testing in all subjects. • To describe the antibody persistence eight months (M8) after the first vaccine administration using HAI method in a subset of subjects who received two half doses of either the 15 μg HA or 3.8 μg HA + AF03 vaccine (amendment 2). • To describe the safety profiles (injection site reactions and systemic events) of each candidate vaccine during the 21 days following each vaccination, and serious adverse events throughout the study in all subjects •To describe the immune response against the A/H1N1 strain using the HAI method 21 days after last vaccination with the 2010-2011 NH seasonal TIV administered 13 months after the first vaccination in a subset of subjects who received two half-doses of either the 15 µg HA or 3.8 µg HA + AF03 A/H1N1 influenza vaccines as primary series (amendment 3).
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were randomized and vaccinated in the study. Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment was also available on site in case of any immediate allergic reactions.
    Background therapy
    Not applicable
    Evidence for comparator
    The non-adjuvanted formulation was chosen based on Sanofi Pasteur experience with seasonal influenza vaccine (Vaxigrip).
    Actual start date of recruitment
    16 Sep 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 401
    Worldwide total number of subjects
    401
    EEA total number of subjects
    401
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    253
    Children (2-11 years)
    148
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Study subjects were enrolled from 16 September 2009 to 07 October 2009 in 15 clinical centers in Finland.

    Pre-assignment
    Screening details
    A total of 401 subjects who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    1.9 μg HA + ½ AF03; 6-11 months
    Arm description
    Subjects aged 6-11 months who received the half-dose of the 3.8 μg HA A/H1N1 pandemic influenza vaccine adjuvanted with AF03 (1.9 μg HA + ½ AF03 group) on Day 0 and 21.
    Arm type
    Experimental

    Investigational medicinal product name
    Swine A/H1N1 Influenza Vaccine (split virion, inactivated, adjuvanted with AF03)
    Investigational medicinal product code
    452
    Other name
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.25 mL dose, intramuscular into the deltoid (subjects ≥1 year of age) or thigh (subjects <1 year of age), two doses 21 days apart.

    Arm title
    3.8 μg HA + ½ AF03; 6-11 months
    Arm description
    Subjects aged 6-11 months who received the half-dose of the 7.5 μg HA A/H1N1 pandemic influenza vaccine adjuvanted with AF03 (3.8 μg HA + ½ AF03 group) on Day 0 and 21.
    Arm type
    Experimental

    Investigational medicinal product name
    Swine A/H1N1 Influenza Vaccine (split virion, inactivated, adjuvanted with AF03)
    Investigational medicinal product code
    452
    Other name
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.25 mL dose, intramuscular into the deltoid (subjects ≥1 year of age) or thigh (subjects <1 year of age), two doses 21 days apart.

    Arm title
    3.8 μg HA + AF03; 6-11 months
    Arm description
    Subjects aged 6-11 months who received a full dose of the 3.8 μg HA A/H1N1 pandemic influenza vaccine adjuvanted with AF03 (3.8 μg HA + AF03 group) on Day 0 and 21.
    Arm type
    Experimental

    Investigational medicinal product name
    Swine A/H1N1 Influenza Vaccine (split virion, inactivated, adjuvanted with AF03)
    Investigational medicinal product code
    452
    Other name
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL dose, intramuscular into the deltoid (subjects ≥1 year of age) or thigh (subjects <1 year of age), two doses 21 days apart.

    Arm title
    7.5 μg HA; 6-11 months
    Arm description
    Subjects aged 6-11 months who received a half-dose of the 7.5 μg HA non-adjuvanted A/H1N1 pandemic influenza vaccine on Day 0 and 21.
    Arm type
    Active comparator

    Investigational medicinal product name
    Swine A/H1N1 Influenza Vaccine (split virion, inactivated)
    Investigational medicinal product code
    448
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.25 mL dose, intramuscular into the deltoid (subjects ≥1 year of age) or thigh (subjects <1 year of age), two doses 21 days apart.

    Arm title
    1.9 μg HA + ½ AF03; 12-35 months
    Arm description
    Subjects aged 12-35 months who received the half-dose of the 3.8 μg HA A/H1N1 pandemic influenza vaccine adjuvanted with AF03 (1.9 μg HA + ½ AF03 group) on Day 0 and 21.
    Arm type
    Experimental

    Investigational medicinal product name
    Swine A/H1N1 Influenza Vaccine (split virion, inactivated, adjuvanted with AF03)
    Investigational medicinal product code
    452
    Other name
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.25 mL dose, intramuscular into the deltoid (subjects ≥1 year of age) or thigh (subjects <1 year of age), two doses 21 days apart.

    Arm title
    3.8 μg HA + ½ AF03; 12-35 months
    Arm description
    Subjects aged 12-35 months who received the half-dose of the 7.5 μg HA A/H1N1 pandemic influenza vaccine adjuvanted with AF03 (3.8 μg HA + ½ AF03 group) on Day 0 and 21.
    Arm type
    Experimental

    Investigational medicinal product name
    Swine A/H1N1 Influenza Vaccine (split virion, inactivated, adjuvanted with AF03)
    Investigational medicinal product code
    452
    Other name
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.25 mL dose, intramuscular into the deltoid (subjects ≥1 year of age) or thigh (subjects <1 year of age), two doses 21 days apart.

    Arm title
    3.8 μg HA + AF03; 12-35 months
    Arm description
    Subjects aged 12-35 months who received a full dose of the 3.8 μg HA A/H1N1 pandemic influenza vaccine adjuvanted with AF03 (3.8 μg HA + AF03 group) on Day 0 and 21.
    Arm type
    Experimental

    Investigational medicinal product name
    Swine A/H1N1 Influenza Vaccine (split virion, inactivated, adjuvanted with AF03)
    Investigational medicinal product code
    452
    Other name
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL dose, intramuscular into the deltoid (subjects ≥1 year of age) or thigh (subjects <1 year of age), two doses 21 days apart.

    Arm title
    7.5 μg HA; 12-35 months
    Arm description
    Subjects aged 12-35 months who received a half-dose of the 7.5 μg HA non-adjuvanted A/H1N1 pandemic influenza vaccine on Day 0 and 21.
    Arm type
    Active comparator

    Investigational medicinal product name
    Swine A/H1N1 Influenza Vaccine (split virion, inactivated)
    Investigational medicinal product code
    448
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.25 mL dose, intramuscular into the deltoid (subjects ≥1 year of age) or thigh (subjects <1 year of age), two doses 21 days apart.

    Number of subjects in period 1
    1.9 μg HA + ½ AF03; 6-11 months 3.8 μg HA + ½ AF03; 6-11 months 3.8 μg HA + AF03; 6-11 months 7.5 μg HA; 6-11 months 1.9 μg HA + ½ AF03; 12-35 months 3.8 μg HA + ½ AF03; 12-35 months 3.8 μg HA + AF03; 12-35 months 7.5 μg HA; 12-35 months
    Started
    48
    50
    52
    51
    48
    50
    52
    50
    Completed
    46
    46
    48
    50
    48
    50
    51
    48
    Not completed
    2
    4
    4
    1
    0
    0
    1
    2
         Protocol deviation
             -
             2
             2
             -
             -
             -
             -
             -
         Adverse event, non-fatal
             1
             1
             -
             -
             -
             -
             1
             1
         Consent withdrawn by subject
             1
             1
             2
             1
             -
             -
             -
             1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    1.9 μg HA + ½ AF03; 6-11 months
    Reporting group description
    Subjects aged 6-11 months who received the half-dose of the 3.8 μg HA A/H1N1 pandemic influenza vaccine adjuvanted with AF03 (1.9 μg HA + ½ AF03 group) on Day 0 and 21.

    Reporting group title
    3.8 μg HA + ½ AF03; 6-11 months
    Reporting group description
    Subjects aged 6-11 months who received the half-dose of the 7.5 μg HA A/H1N1 pandemic influenza vaccine adjuvanted with AF03 (3.8 μg HA + ½ AF03 group) on Day 0 and 21.

    Reporting group title
    3.8 μg HA + AF03; 6-11 months
    Reporting group description
    Subjects aged 6-11 months who received a full dose of the 3.8 μg HA A/H1N1 pandemic influenza vaccine adjuvanted with AF03 (3.8 μg HA + AF03 group) on Day 0 and 21.

    Reporting group title
    7.5 μg HA; 6-11 months
    Reporting group description
    Subjects aged 6-11 months who received a half-dose of the 7.5 μg HA non-adjuvanted A/H1N1 pandemic influenza vaccine on Day 0 and 21.

    Reporting group title
    1.9 μg HA + ½ AF03; 12-35 months
    Reporting group description
    Subjects aged 12-35 months who received the half-dose of the 3.8 μg HA A/H1N1 pandemic influenza vaccine adjuvanted with AF03 (1.9 μg HA + ½ AF03 group) on Day 0 and 21.

    Reporting group title
    3.8 μg HA + ½ AF03; 12-35 months
    Reporting group description
    Subjects aged 12-35 months who received the half-dose of the 7.5 μg HA A/H1N1 pandemic influenza vaccine adjuvanted with AF03 (3.8 μg HA + ½ AF03 group) on Day 0 and 21.

    Reporting group title
    3.8 μg HA + AF03; 12-35 months
    Reporting group description
    Subjects aged 12-35 months who received a full dose of the 3.8 μg HA A/H1N1 pandemic influenza vaccine adjuvanted with AF03 (3.8 μg HA + AF03 group) on Day 0 and 21.

    Reporting group title
    7.5 μg HA; 12-35 months
    Reporting group description
    Subjects aged 12-35 months who received a half-dose of the 7.5 μg HA non-adjuvanted A/H1N1 pandemic influenza vaccine on Day 0 and 21.

    Reporting group values
    1.9 μg HA + ½ AF03; 6-11 months 3.8 μg HA + ½ AF03; 6-11 months 3.8 μg HA + AF03; 6-11 months 7.5 μg HA; 6-11 months 1.9 μg HA + ½ AF03; 12-35 months 3.8 μg HA + ½ AF03; 12-35 months 3.8 μg HA + AF03; 12-35 months 7.5 μg HA; 12-35 months Total
    Number of subjects
    48 50 52 51 48 50 52 50 401
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    48 50 52 51 13 15 14 10 253
        Children (2-11 years)
    0 0 0 0 35 35 38 40 148
        Adolescents (12-17 years)
    0 0 0 0 0 0 0 0 0
        Adults (18-64 years)
    0 0 0 0 0 0 0 0 0
        From 65-84 years
    0 0 0 0 0 0 0 0 0
        85 years and over
    0 0 0 0 0 0 0 0 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    9.4 ± 1.5 9 ± 1.7 8.9 ± 1.9 9.1 ± 1.4 27.3 ± 6.4 26.3 ± 6.3 27.6 ± 6.4 27.1 ± 5.9 -
    Gender categorical
    Units: Subjects
        Female
    25 27 25 27 22 24 28 21 199
        Male
    23 23 27 24 26 26 24 29 202
    Influenza vaccination 2008/2009
    Units: Subjects
        Yes
    0 0 0 0 24 27 31 26 108
        No
    44 47 48 50 21 20 20 24 274
        Unknown
    0 0 0 0 3 3 1 0 7
        Not applicable
    4 3 4 1 0 0 0 0 12
    Influenza vaccination 2007/2008
    Units: Subjects
        Yes
    0 0 0 0 17 18 20 21 76
        No
    0 1 0 0 21 23 25 22 92
        Unknown
    0 0 0 0 2 2 0 0 4
        Not applicable
    48 49 52 51 8 7 7 7 229
    Influenza vaccination 2006/2007
    Units: Subjects
        Yes
    0 0 0 0 1 0 0 0 1
        No
    0 0 0 0 15 15 21 15 66
        Uknown
    0 0 0 0 1 0 0 0 1
        Not applicable
    48 50 52 51 31 35 31 35 333
    Experience influenza infection during the 2008/2009 season
    Units: Subjects
        Yes
    0 0 0 1 1 1 1 2 6
        No
    47 50 52 49 44 48 49 46 385
        Unknown
    1 0 0 1 3 1 2 2 10
    Subject in contact with a confirmed and/or probable case of H1N1 within 8 months prior to enrollment
    Units: Subjects
        Yes
    0 2 0 0 0 0 0 0 2
        No
    48 47 52 51 47 49 52 49 395
        Unknown
    0 1 0 0 1 1 0 1 4

    End points

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    End points reporting groups
    Reporting group title
    1.9 μg HA + ½ AF03; 6-11 months
    Reporting group description
    Subjects aged 6-11 months who received the half-dose of the 3.8 μg HA A/H1N1 pandemic influenza vaccine adjuvanted with AF03 (1.9 μg HA + ½ AF03 group) on Day 0 and 21.

    Reporting group title
    3.8 μg HA + ½ AF03; 6-11 months
    Reporting group description
    Subjects aged 6-11 months who received the half-dose of the 7.5 μg HA A/H1N1 pandemic influenza vaccine adjuvanted with AF03 (3.8 μg HA + ½ AF03 group) on Day 0 and 21.

    Reporting group title
    3.8 μg HA + AF03; 6-11 months
    Reporting group description
    Subjects aged 6-11 months who received a full dose of the 3.8 μg HA A/H1N1 pandemic influenza vaccine adjuvanted with AF03 (3.8 μg HA + AF03 group) on Day 0 and 21.

    Reporting group title
    7.5 μg HA; 6-11 months
    Reporting group description
    Subjects aged 6-11 months who received a half-dose of the 7.5 μg HA non-adjuvanted A/H1N1 pandemic influenza vaccine on Day 0 and 21.

    Reporting group title
    1.9 μg HA + ½ AF03; 12-35 months
    Reporting group description
    Subjects aged 12-35 months who received the half-dose of the 3.8 μg HA A/H1N1 pandemic influenza vaccine adjuvanted with AF03 (1.9 μg HA + ½ AF03 group) on Day 0 and 21.

    Reporting group title
    3.8 μg HA + ½ AF03; 12-35 months
    Reporting group description
    Subjects aged 12-35 months who received the half-dose of the 7.5 μg HA A/H1N1 pandemic influenza vaccine adjuvanted with AF03 (3.8 μg HA + ½ AF03 group) on Day 0 and 21.

    Reporting group title
    3.8 μg HA + AF03; 12-35 months
    Reporting group description
    Subjects aged 12-35 months who received a full dose of the 3.8 μg HA A/H1N1 pandemic influenza vaccine adjuvanted with AF03 (3.8 μg HA + AF03 group) on Day 0 and 21.

    Reporting group title
    7.5 μg HA; 12-35 months
    Reporting group description
    Subjects aged 12-35 months who received a half-dose of the 7.5 μg HA non-adjuvanted A/H1N1 pandemic influenza vaccine on Day 0 and 21.

    Primary: Geometric Mean Titers (GMTs) of Antibody Assayed by HAI Method Against A/California (H1N1) Strain in Subjects Age 6 to 11 Months After Vaccination with Intramuscular Inactivated, Split-virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Geometric Mean Titers (GMTs) of Antibody Assayed by HAI Method Against A/California (H1N1) Strain in Subjects Age 6 to 11 Months After Vaccination with Intramuscular Inactivated, Split-virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant [1] [2]
    End point description
    Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 and Day 42 post-vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the age group specified.
    End point values
    1.9 μg HA + ½ AF03; 6-11 months 3.8 μg HA + ½ AF03; 6-11 months 3.8 μg HA + AF03; 6-11 months 7.5 μg HA; 6-11 months
    Number of subjects analysed
    48
    50
    52
    51
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Day 0
    5 (5 to 5)
    5 (5 to 5)
    5 (5 to 5)
    5 (5 to 5)
        Day 21
    200 (154 to 259)
    256 (204 to 322)
    290 (238 to 354)
    18.4 (14.1 to 24)
        Day 42
    3008 (2474 to 3656)
    2500 (2102 to 2974)
    3241 (2777 to 3783)
    184 (142 to 239)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of Antibody Assayed by HAI Method Against A/California (H1N1) Strain in Subjects Age 12-35 Months After Vaccination with Intramuscular Inactivated, Split-virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Geometric Mean Titers (GMTs) of Antibody Assayed by HAI Method Against A/California (H1N1) Strain in Subjects Age 12-35 Months After Vaccination with Intramuscular Inactivated, Split-virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant [3] [4]
    End point description
    Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 and Day 42 post-vaccination
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the age group specified.
    End point values
    1.9 μg HA + ½ AF03; 12-35 months 3.8 μg HA + ½ AF03; 12-35 months 3.8 μg HA + AF03; 12-35 months 7.5 μg HA; 12-35 months
    Number of subjects analysed
    48
    50
    52
    50
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Day 0
    5.04 (4.96 to 5.11)
    5.21 (4.79 to 5.67)
    5 (5 to 5)
    5 (5 to 5)
        Day 21
    253 (191 to 337)
    220 (170 to 285)
    409 (334 to 502)
    28.3 (19.8 to 40.4)
        Day 42
    2736 (2221 to 3370)
    2524 (2143 to 2973)
    3748 (3212 to 4374)
    244 (174 to 342)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 6-Months with Antibody Titers ≥ 40 (1/dil) Assayed by HAI Method Against A/California (H1N1) Strain After Vaccination with Intramuscular Inactivated, Split-virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Percentage of Subjects Age 6-Months with Antibody Titers ≥ 40 (1/dil) Assayed by HAI Method Against A/California (H1N1) Strain After Vaccination with Intramuscular Inactivated, Split-virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant [5] [6]
    End point description
    Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 and Day 42 post-vaccination
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the age group specified.
    End point values
    1.9 μg HA + ½ AF03; 6-11 months 3.8 μg HA + ½ AF03; 6-11 months 3.8 μg HA + AF03; 6-11 months 7.5 μg HA; 6-11 months
    Number of subjects analysed
    48
    50
    52
    51
    Units: Percentage of subjects
    number (not applicable)
        Day 0
    0
    0
    0
    0
        Day 21
    95.7
    97.9
    100
    32.7
        Day 42
    100
    100
    100
    98
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 12-35 Months with Antibody Titers ≥40 (1/dil) Assayed by HAI Method Against A/California (H1N1) Strain After Vaccination with Intramuscular Inactivated, Split-virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Percentage of Subjects Age 12-35 Months with Antibody Titers ≥40 (1/dil) Assayed by HAI Method Against A/California (H1N1) Strain After Vaccination with Intramuscular Inactivated, Split-virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant [7] [8]
    End point description
    Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 and Day 42 post-vaccination
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the age group specified.
    End point values
    1.9 μg HA + ½ AF03; 12-35 months 3.8 μg HA + ½ AF03; 12-35 months 3.8 μg HA + AF03; 12-35 months 7.5 μg HA; 12-35 months
    Number of subjects analysed
    48
    50
    52
    50
    Units: Percentage of subjects
    number (not applicable)
        Day 0
    0
    2
    0
    0
        Day 21
    97.8
    98
    100
    34
        Day 42
    100
    100
    100
    97.9
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 6-11 Months Achieving Seroconversion or significant increase in Antibody Assayed by HAI Method Against A/California (H1N1) Strain After Intramuscular Inactivated, Split-virion A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Percentage of Subjects Age 6-11 Months Achieving Seroconversion or significant increase in Antibody Assayed by HAI Method Against A/California (H1N1) Strain After Intramuscular Inactivated, Split-virion A/H1N1 Influenza Vaccine With or Without Adjuvant [9] [10]
    End point description
    Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method. Seroconversion was defined as subjects with pre-vaccination titer <10 (1/dil) on Day 0, post-vaccination titer ≥40 (1/dil) or significant increase for subjects with pre-vaccination titer ≥10 (1/dil), ≥4-fold increase of the titer after vaccination (post/pre).
    End point type
    Primary
    End point timeframe
    Day 21 and Day 42 post-vaccination
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the age group specified.
    End point values
    1.9 μg HA + ½ AF03; 6-11 months 3.8 μg HA + ½ AF03; 6-11 months 3.8 μg HA + AF03; 6-11 months 7.5 μg HA; 6-11 months
    Number of subjects analysed
    48
    50
    52
    51
    Units: Percentage of subjects
    number (not applicable)
        Day 21
    95.7
    97.9
    100
    32.7
        Day 42
    100
    100
    100
    98
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 12-35 Months Achieving Seroconversion or significant increase in Antibody Assayed by HAI Method Against A/California (H1N1) Strain After Intramuscular Inactivated, Split-virion A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Percentage of Subjects Age 12-35 Months Achieving Seroconversion or significant increase in Antibody Assayed by HAI Method Against A/California (H1N1) Strain After Intramuscular Inactivated, Split-virion A/H1N1 Influenza Vaccine With or Without Adjuvant [11] [12]
    End point description
    Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method. Seroconversion was defined as subjects with pre-vaccination titer <10 (1/dil) on Day 0, post-vaccination titer ≥40 (1/dil) or significant increase for subjects with pre-vaccination titer ≥10 (1/dil), ≥4-fold increase of the titer after vaccination (post/pre).
    End point type
    Primary
    End point timeframe
    Day 21 and Day 42 post-vaccination
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the age group specified.
    End point values
    1.9 μg HA + ½ AF03; 12-35 months 3.8 μg HA + ½ AF03; 12-35 months 3.8 μg HA + AF03; 12-35 months 7.5 μg HA; 12-35 months
    Number of subjects analysed
    48
    50
    52
    50
    Units: Percentage of subjects
    number (not applicable)
        Day 21
    97.8
    98
    100
    34
        Day 42
    100
    100
    100
    97.9
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 6 to 11 Months with Neutralizing Antibody Titers ≥40 (1/dil) Assayed by Seroneutralization Method Against A/California (H1N1) Strain After Intramuscular Inactivated, Split-virion A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Percentage of Subjects Age 6 to 11 Months with Neutralizing Antibody Titers ≥40 (1/dil) Assayed by Seroneutralization Method Against A/California (H1N1) Strain After Intramuscular Inactivated, Split-virion A/H1N1 Influenza Vaccine With or Without Adjuvant [13] [14]
    End point description
    Immunogenicity was evaluated using the seroneutralization method.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 and Day 42 post-vaccination
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the age group specified.
    End point values
    1.9 μg HA + ½ AF03; 6-11 months 3.8 μg HA + ½ AF03; 6-11 months 3.8 μg HA + AF03; 6-11 months 7.5 μg HA; 6-11 months
    Number of subjects analysed
    48
    50
    52
    51
    Units: Percentage of subjects
    number (not applicable)
        Day 0
    0
    0
    0
    0
        Day 21
    97.9
    100
    97.8
    69.4
        Day 42
    100
    100
    100
    100
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 12-35 Months with Neutralizing Antibody Titers ≥ 40 (1/dil) Assayed by Seroneutralization Method Against A/California (H1N1) Strain After Intramuscular Inactivated, Split-virion A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Percentage of Subjects Age 12-35 Months with Neutralizing Antibody Titers ≥ 40 (1/dil) Assayed by Seroneutralization Method Against A/California (H1N1) Strain After Intramuscular Inactivated, Split-virion A/H1N1 Influenza Vaccine With or Without Adjuvant [15] [16]
    End point description
    Immunogenicity was evaluated using the seroneutralization method.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 and Day 42 post-vaccination
    Notes
    [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the age group specified.
    End point values
    1.9 μg HA + ½ AF03; 12-35 months 3.8 μg HA + ½ AF03; 12-35 months 3.8 μg HA + AF03; 12-35 months 7.5 μg HA; 12-35 months
    Number of subjects analysed
    48
    50
    52
    50
    Units: Percentage of subjects
    number (not applicable)
        Day 0
    0
    0
    1.9
    0
        Day 21
    100
    98
    100
    76.6
        Day 42
    100
    100
    100
    97.9
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of Neutralizing Antibody Assayed by Seroneutralization Method Against A/California (H1N1) Strain in Subjects Age 6-11 Months After Intramuscular Inactivated, Split-virion A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Geometric Mean Titers (GMTs) of Neutralizing Antibody Assayed by Seroneutralization Method Against A/California (H1N1) Strain in Subjects Age 6-11 Months After Intramuscular Inactivated, Split-virion A/H1N1 Influenza Vaccine With or Without Adjuvant [17] [18]
    End point description
    Immunogenicity was evaluated using the seroneutralization method.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 and Day 42 post-vaccination
    Notes
    [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the age group specified.
    End point values
    1.9 μg HA + ½ AF03; 6-11 months 3.8 μg HA + ½ AF03; 6-11 months 3.8 μg HA + AF03; 6-11 months 7.5 μg HA; 6-11 months
    Number of subjects analysed
    48
    50
    52
    51
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Day 0
    5.18 (4.82 to 5.57)
    5 (5 to 5)
    5 (5 to 5)
    5 (5 to 5)
        Day 21
    817 (583 to 1146)
    1196 (918 to 1558)
    1179 (849 to 1636)
    56.4 (39.1 to 81.3)
        Day 42
    9546 (9085 to 10031)
    9214 (8526 to 9956)
    9969 (9612 to 10340)
    1035 (780 to 1372)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of Neutralizing Antibody Assayed by Seroneutralization Method Against A/California (H1N1) Strain in Subjects Age 12-35 Months After Intramuscular Inactivated, Split-virion A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Geometric Mean Titers (GMTs) of Neutralizing Antibody Assayed by Seroneutralization Method Against A/California (H1N1) Strain in Subjects Age 12-35 Months After Intramuscular Inactivated, Split-virion A/H1N1 Influenza Vaccine With or Without Adjuvant [19] [20]
    End point description
    Immunogenicity was evaluated using the seroneutralization method.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 and Day 42 post-vaccination
    Notes
    [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the age group specified.
    End point values
    1.9 μg HA + ½ AF03; 12-35 months 3.8 μg HA + ½ AF03; 12-35 months 3.8 μg HA + AF03; 12-35 months 7.5 μg HA; 12-35 months
    Number of subjects analysed
    48
    50
    52
    50
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Day 0
    5.09 (4.91 to 5.28)
    5 (5 to 5)
    5.25 (4.76 to 5.8)
    5 (5 to 5)
        Day 21
    1113 (853 to 1452)
    981 (712 to 1351)
    1875 (1491 to 2358)
    95.1 (59.8 to 151)
        Day 42
    8539 (7617 to 9571)
    9158 (8450 to 9926)
    9761 (9185 to 10372)
    1170 (791 to 1730)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 6-11 Months with 2- and 4-fold Increase in Neutralizing Antibody Titers Assayed by Seroneutralization Against A/California (H1N1) Strain After Inactivated, Split-virion A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Percentage of Subjects Age 6-11 Months with 2- and 4-fold Increase in Neutralizing Antibody Titers Assayed by Seroneutralization Against A/California (H1N1) Strain After Inactivated, Split-virion A/H1N1 Influenza Vaccine With or Without Adjuvant [21] [22]
    End point description
    Immunogenicity was evaluated using the seroneutralization method.
    End point type
    Primary
    End point timeframe
    Day 21 and Day 42 post-vaccination
    Notes
    [21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the age group specified.
    End point values
    1.9 μg HA + ½ AF03; 6-11 months 3.8 μg HA + ½ AF03; 6-11 months 3.8 μg HA + AF03; 6-11 months 7.5 μg HA; 6-11 months
    Number of subjects analysed
    48
    50
    52
    51
    Units: Percentage of subjects
    number (not applicable)
        ≥2-fold increase from Day 0; Day 21
    97.9
    100
    97.8
    89.8
        ≥2-fold increase from Day 0; Day 42
    100
    100
    100
    100
        ≥4-fold increase from Day 0; Day 21
    97.9
    100
    97.8
    77.6
        ≥4-fold increase from Day 0; Day 42
    100
    100
    100
    100
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 12-35 Months with 2- and 4-fold Increase in Neutralizing Antibody Titers Assayed by Seroneutralization Against A/California (H1N1) Strain After Inactivated, Split-virion A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Percentage of Subjects Age 12-35 Months with 2- and 4-fold Increase in Neutralizing Antibody Titers Assayed by Seroneutralization Against A/California (H1N1) Strain After Inactivated, Split-virion A/H1N1 Influenza Vaccine With or Without Adjuvant [23] [24]
    End point description
    Immunogenicity was evaluated using the seroneutralization method.
    End point type
    Primary
    End point timeframe
    Day 21 and Day 42 post-vaccination
    Notes
    [23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the age group specified.
    End point values
    1.9 μg HA + ½ AF03; 12-35 months 3.8 μg HA + ½ AF03; 12-35 months 3.8 μg HA + AF03; 12-35 months 7.5 μg HA; 12-35 months
    Number of subjects analysed
    48
    50
    52
    50
    Units: Percentage of subjects
    number (not applicable)
        ≥2-fold increase from Day 0; Day 21
    100
    98
    100
    89.4
        ≥2-fold increase from Day 0; Day 42
    100
    100
    100
    100
        ≥4-fold increase from Day 0; Day 21
    100
    98
    100
    85.1
        ≥4-fold increase from Day 0; Day 42
    100
    100
    100
    97.9
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of Antibody Assayed by SRH Method Against A/California (H1N1) Strain in Subjects Age 6 to 11 Months Old Before and After Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Geometric Mean Titers (GMTs) of Antibody Assayed by SRH Method Against A/California (H1N1) Strain in Subjects Age 6 to 11 Months Old Before and After Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant [25] [26]
    End point description
    Immunogenicity was evaluated using Single radial hemolysis (SRH) testing.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 and Day 42 post-vaccination
    Notes
    [25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the age group specified.
    End point values
    1.9 μg HA + ½ AF03; 6-11 months 3.8 μg HA + ½ AF03; 6-11 months 3.8 μg HA + AF03; 6-11 months 7.5 μg HA; 6-11 months
    Number of subjects analysed
    48
    50
    52
    51
    Units: Titers (mm2)
    geometric mean (confidence interval 95%)
        Day 0
    4.53 (4.07 to 5.05)
    4.32 (3.95 to 4.72)
    4.71 (4.19 to 5.3)
    4.67 (4.13 to 5.27)
        Day 21
    75 (67.9 to 82.8)
    77.3 (70.8 to 84.5)
    78.6 (72.2 to 85.6)
    33.1 (29.6 to 37.1)
        Day 42
    115 (110 to 121)
    111 (106 to 116)
    116 (112 to 121)
    53.5 (49.1 to 58.2)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers of Antibody Assayed by SRH Against A/California (H1N1) Strain in Subjects Age 12-35 Months Before and After Vaccination with Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Geometric Mean Titers of Antibody Assayed by SRH Against A/California (H1N1) Strain in Subjects Age 12-35 Months Before and After Vaccination with Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant [27] [28]
    End point description
    Immunogenicity was evaluated using Single radial hemolysis (SRH) testing.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 and Day 42 post-vaccination
    Notes
    [27] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [28] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the age group specified.
    End point values
    1.9 μg HA + ½ AF03; 12-35 months 3.8 μg HA + ½ AF03; 12-35 months 3.8 μg HA + AF03; 12-35 months 7.5 μg HA; 12-35 months
    Number of subjects analysed
    48
    50
    52
    50
    Units: Titers (mm2)
    geometric mean (confidence interval 95%)
        Day 0
    5.23 (4.4 to 6.21)
    6.18 (5.13 to 7.44)
    6.45 (5.31 to 7.83)
    5.35 (4.41 to 6.49)
        Day 21
    83.9 (77.5 to 90.8)
    77.1 (68.6 to 86.7)
    96.3 (89.5 to 104)
    43.2 (36.4 to 51.3)
        Day 42
    119 (115 to 124)
    112 (107 to 118)
    124 (121 to 128)
    61 (52.8 to 70.4)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 6 to 11 Months Old With Seroprotection Against A/California (H1N1) Strain Following Vaccination with Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Percentage of Subjects Age 6 to 11 Months Old With Seroprotection Against A/California (H1N1) Strain Following Vaccination with Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant [29] [30]
    End point description
    Immunogenicity was evaluated using Single radial hemolysis (SRH) testing. Seroprotection was defined as titers ≥25 mm² on Day 0, Day 21 and Day 42.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 and Day 42 post-vaccination
    Notes
    [29] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the age group specified.
    [30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the age group specified.
    End point values
    1.9 μg HA + ½ AF03; 6-11 months 3.8 μg HA + ½ AF03; 6-11 months 3.8 μg HA + AF03; 6-11 months 7.5 μg HA; 6-11 months
    Number of subjects analysed
    48
    50
    52
    51
    Units: Percentage of subjects
    number (not applicable)
        Day 0
    0
    0
    0
    0
        Day 21
    97.9
    97.9
    100
    77.6
        Day 42
    100
    100
    100
    100
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 12 to 35 Months Old With Seroprotection Against A/California (H1N1) Strain Following Vaccination with Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Percentage of Subjects Age 12 to 35 Months Old With Seroprotection Against A/California (H1N1) Strain Following Vaccination with Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant [31] [32]
    End point description
    Immunogenicity was evaluated using Single radial hemolysis (SRH) testing. Seroprotection was defined as titers ≥25 mm² on Day 0, Day 21 and Day 42.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 and Day 42 post-vaccination
    Notes
    [31] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [32] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the age group specified.
    End point values
    1.9 μg HA + ½ AF03; 12-35 months 3.8 μg HA + ½ AF03; 12-35 months 3.8 μg HA + AF03; 12-35 months 7.5 μg HA; 12-35 months
    Number of subjects analysed
    48
    50
    52
    50
    Units: Percentage of subjects
    number (not applicable)
        Day 0
    2.1
    0
    5.8
    4
        Day 21
    100
    98
    100
    78.7
        Day 42
    100
    100
    100
    100
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 12 to 35 Months Old Reporting Solicited Injection-site or Systemic Reactions After Any Vaccination with Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Percentage of Subjects Age 12 to 35 Months Old Reporting Solicited Injection-site or Systemic Reactions After Any Vaccination with Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant [33] [34]
    End point description
    Solicited inj. site: Tenderness (<24 mths)/Pain (≥24 mths), Erythema, Swelling, Induration and Ecchymosis. Solicited systemic reactions (<24 mths): Fever, Vomiting, Crying abnormal, Drowsiness, Appetite loss, Irritability. Solicited systemic reactions (≥24 mths): Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 Solicited inj. site reactions: Tenderness–Cries when injected limb is moved or the movement is reduced; Pain–Incapacitating, prevents performance of usual activities; Erythema, Swelling, Induration, and Ecchymosis–≥5 cm. Grade 3 Solicited systemic reactions (<24 mths): Fever–>39.5˚C; Vomiting–≥6 episodes/24 hours or requiring parenteral hydration; Crying abnormal - >3 hours; Drowsiness–Sleeping most of the time or difficult to wake; Appetite loss–Refusing ≥3 feeds/meals or refusing most feeds/meals; Irritability–Inconsolable. Grade 3 Solicited systemic reactions (≥24 mths): Fever–≥39.0˚C; Headache, Malaise, Myalgia, and Shivering–Significant, prevents daily activity.
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 7 post-any vaccination
    Notes
    [33] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [34] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the age group specified.
    End point values
    1.9 μg HA + ½ AF03; 12-35 months 3.8 μg HA + ½ AF03; 12-35 months 3.8 μg HA + AF03; 12-35 months 7.5 μg HA; 12-35 months
    Number of subjects analysed
    48
    50
    52
    50
    Units: Percentage of subjects
    number (not applicable)
        Inj. site Pain/Tenderness
    58.3
    56
    55.8
    38.8
        Grade 3 Inj. site Pain/Tenderness
    0
    0
    3.8
    0
        Inj. site Erythema
    37.5
    32
    53.8
    24.5
        Grade 3 Inj. site Erythema
    4.2
    6
    9.6
    0
        Inj. site Swelling
    14.6
    12
    23.1
    14.3
        Grade 3 Inj. site Swelling
    4.2
    4
    5.8
    0
        Inj. site Induration
    20.8
    30
    19.2
    10.2
        Grade 3 Inj. site Induration
    0
    0
    1.9
    2
        Inj. site Ecchymosis
    12.5
    28
    9.6
    16.3
        Grade 3 Inj. site Ecchymosis
    0
    0
    0
    0
        Vomiting
    7.1
    13.3
    0
    0
        Grade 3 Vomiting
    0
    0
    0
    0
        Crying abnormal
    28.6
    46.7
    53.3
    50
        Grade 3 Crying abnormal
    0
    0
    6.7
    10
        Drowsiness
    28.6
    26.7
    40
    40
        Grade 3 Drowsiness
    0
    0
    0
    10
        Appetite lost
    50
    60
    73.3
    40
        Grade 3 Appetite lost
    0
    0
    13.3
    10
        Irritability
    35.7
    60
    66.7
    60
        Grade 3 Irritability
    0
    13.3
    6.7
    20
        Headache
    8.8
    2.9
    5.4
    5.1
        Grade 3 Headache
    0
    0
    0
    0
        Malaise
    29.4
    8.6
    10.8
    25.6
        Grade 3 Malaise
    14.7
    0
    0
    2.6
        Myalgia
    26.5
    14.3
    24.3
    12.8
        Grade 3 Myalgia
    2.9
    0
    0
    0
        Fever; 12 to 23 months
    28.6
    20
    26.7
    20
        Grade 3 Fever; 12 to 23 months
    14.3
    0
    0
    0
        Fever; 24 to 35 months
    11.8
    17.1
    21.6
    5.1
        Grade 3 Fever; 24 to 35 months
    2.9
    2.9
    0
    0
        Shivering
    17.6
    2.9
    24.3
    2.6
        Grade 3 Shivering
    2.9
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 6 to 11 Months Old Reporting Solicited Injection-site or Systemic Reactions After Any Vaccination with Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Percentage of Subjects Age 6 to 11 Months Old Reporting Solicited Injection-site or Systemic Reactions After Any Vaccination with Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant [35] [36]
    End point description
    Solicited inj. site: Tenderness (<24 mths)/Pain (≥24 mths), Erythema, Swelling, Induration and Ecchymosis. Solicited systemic reactions (<24 mths): Fever, Vomiting, Crying abnormal, Drowsiness, Appetite loss, Irritability. Solicited systemic reactions (≥24 mths): Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 Solicited inj. site reactions: Tenderness–Cries when injected limb is moved or the movement is reduced; Pain–Incapacitating, prevents performance of usual activities; Erythema, Swelling, Induration, and Ecchymosis–≥5 cm. Grade 3 Solicited systemic reactions (<24 mths): Fever–>39.5˚C; Vomiting–≥6 episodes/24 hours or requiring parenteral hydration; Crying abnormal - >3 hours; Drowsiness–Sleeping most of the time or difficult to wake; Appetite loss–Refusing ≥3 feeds/meals or refusing most feeds/meals; Irritability–Inconsolable. Grade 3 Solicited systemic reactions (≥24 mths): Fever–≥39.0˚C; Headache, Malaise, Myalgia, and Shivering–Significant, prevents daily activity.
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 7 post-any vaccination
    Notes
    [35] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [36] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the age group specified.
    End point values
    1.9 μg HA + ½ AF03; 6-11 months 3.8 μg HA + ½ AF03; 6-11 months 3.8 μg HA + AF03; 6-11 months 7.5 μg HA; 6-11 months
    Number of subjects analysed
    48
    50
    52
    51
    Units: Percentage of subjects
    number (not applicable)
        Inj. site Tenderness
    33.3
    24.5
    46.2
    17.6
        Grade 3 Inj. site Tenderness
    0
    0
    0
    0
        Inj. site Erythema
    25
    22
    50
    17.6
        Grade 3 Inj. site Erythema
    2.1
    4
    0
    0
        Inj. site Swelling
    12.5
    8.2
    17.3
    3.9
        Grade 3 Inj. site Swelling
    0
    2
    0
    0
        Inj. site Induration
    25
    24.5
    36.5
    17.6
        Grade 3 Inj. site Induration
    0
    4.1
    1.9
    0
        Inj. site Ecchymosis
    6.3
    14.3
    13.5
    9.8
        Grade 3 Inj. site Ecchymosis
    0
    0
    0
    0
        Fever
    35.4
    46
    42.3
    13.7
        Grade 3 Fever
    2.1
    6
    3.8
    0
        Vomiting
    33.3
    22.4
    23.1
    13.7
        Grade 3 Vomiting
    0
    0
    0
    0
        Crying abnormal
    60.4
    53.1
    57.7
    52.9
        Grade 3 Crying abnormal
    8.3
    4.1
    1.9
    0
        Drowsiness
    43.8
    28.6
    51.9
    33.3
        Grade 3 Drowsiness
    4.2
    0
    1.9
    2
        Appetite lost
    47.9
    42.9
    48.1
    49
        Grade 3 Appetite lost
    2.1
    2
    0
    3.9
        Irritability
    66.7
    57.1
    69.2
    76.5
        Grade 3 Irritability
    2.1
    2
    1.9
    3.9
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 24-35 Months with at Least One Solicited Reaction Listed in the EMA Note for Guidance Within 3 Days After Any and Each Vaccination with Intramuscular Inactivated, Split Virion A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Percentage of Subjects Age 24-35 Months with at Least One Solicited Reaction Listed in the EMA Note for Guidance Within 3 Days After Any and Each Vaccination with Intramuscular Inactivated, Split Virion A/H1N1 Influenza Vaccine With or Without Adjuvant [37] [38]
    End point description
    Solicited injection site reactions: Injection site induration ≥5 cm for at least 4 consecutive days and Injection site ecchymosis. Solicited systemic reactions: Pyrexia (recorded temperature > 38°C) for at least 1 day, Malaise, and Shivering.
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 3 post-any and each vaccination
    Notes
    [37] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [38] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the age group specified.
    End point values
    1.9 μg HA + ½ AF03; 12-35 months 3.8 μg HA + ½ AF03; 12-35 months 3.8 μg HA + AF03; 12-35 months 7.5 μg HA; 12-35 months
    Number of subjects analysed
    34
    35
    37
    40
    Units: Percentage of subjects
    number (not applicable)
        Reaction listed in the EMA recommendations
    35.3
    40
    32.4
    38.5
        Reaction listed in EMA recommendations;Post-inj. 1
    20.6
    14.3
    21.6
    25.6
        Reaction listed in EMA recommendations;Post-inj. 2
    29.4
    28.6
    21.6
    23.7
        Inj. site Induration ≥5 cm for 4 days
    0
    0
    0
    0
        Inj. site Induration ≥5 cm for 4 days; Post-inj. 1
    0
    0
    0
    0
        Inj. site Induration ≥5 cm for 4 days; Post-inj. 2
    0
    0
    0
    0
        Inj. site Ecchymosis
    11.8
    25.7
    10.8
    17.9
        Inj. site Ecchymosis; Post-inj. 1
    5.9
    11.4
    5.4
    12.8
        Inj. site Ecchymosis; Post-inj. 2
    5.9
    17.1
    5.4
    10.5
        Pyrexia (temp. > 38°C) for 1 day
    11.8
    8.6
    10.8
    2.6
        Pyrexia (temp. > 38°C) for 1 day; Post-inj. 1
    0
    2.9
    2.7
    2.6
        Pyrexia (temp. > 38°C) for 1 day; Post-inj. 2
    11.8
    5.7
    8.1
    0
        Malaise
    29.4
    5.7
    8.1
    20.5
        Malaise; Post-inj. 1
    17.6
    0
    5.6
    7.7
        Malaise; Post-inj. 2
    17.6
    5.7
    8.1
    13.2
        Shivering
    17.6
    0
    21.6
    2.6
        Shivering; Post-inj. 1
    5.9
    0
    16.7
    2.6
        Shivering; Post-inj. 2
    17.6
    0
    10.8
    2.6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    1.9 μg HA + ½ AF03; 6-11 months
    Reporting group description
    Subjects aged 6-11 months who received the half-dose of the 3.8 μg HA A/H1N1 pandemic influenza vaccine adjuvanted with AF03 (1.9 μg HA + ½ AF03 group) on Day 0 and 21.

    Reporting group title
    3.8 μg HA + ½ AF03; 6-11 months
    Reporting group description
    Subjects aged 6-11 months who received the half-dose of the 7.5 μg HA A/H1N1 pandemic influenza vaccine adjuvanted with AF03 (3.8 μg HA + ½ AF03 group) on Day 0 and 21.

    Reporting group title
    3.8 μg HA + AF03; 6-11 months
    Reporting group description
    Subjects aged 6-11 months who received a full dose of the 3.8 μg HA A/H1N1 pandemic influenza vaccine adjuvanted with AF03 (3.8 μg HA + AF03 group) on Day 0 and 21.

    Reporting group title
    7.5 μg HA; 6-11 months
    Reporting group description
    Subjects aged 6-11 months who received a half-dose of the 7.5 μg HA non-adjuvanted A/H1N1 pandemic influenza vaccine on Day 0 and 21.

    Reporting group title
    1.9 μg HA + ½ AF03; 12-35 months
    Reporting group description
    Subjects aged 12-35 months who received the half-dose of the 3.8 μg HA A/H1N1 pandemic influenza vaccine adjuvanted with AF03 (1.9 μg HA + ½ AF03 group) on Day 0 and 21.

    Reporting group title
    3.8 μg HA + ½ AF03; 12-35 months
    Reporting group description
    Subjects aged 12-35 months who received the half-dose of the 7.5 μg HA A/H1N1 pandemic influenza vaccine adjuvanted with AF03 (3.8 μg HA + ½ AF03 group) on Day 0 and 21.

    Reporting group title
    3.8 μg HA + AF03; 12-35 months
    Reporting group description
    Subjects aged 12-35 months who received a full dose of the 3.8 μg HA A/H1N1 pandemic influenza vaccine adjuvanted with AF03 (3.8 μg HA + AF03 group) on Day 0 and 21.

    Reporting group title
    7.5 μg HA; 12-35 months
    Reporting group description
    Subjects aged 12-35 months who received a half-dose of the 7.5 μg HA non-adjuvanted A/H1N1 pandemic influenza vaccine on Day 0 and 21.

    Serious adverse events
    1.9 μg HA + ½ AF03; 6-11 months 3.8 μg HA + ½ AF03; 6-11 months 3.8 μg HA + AF03; 6-11 months 7.5 μg HA; 6-11 months 1.9 μg HA + ½ AF03; 12-35 months 3.8 μg HA + ½ AF03; 12-35 months 3.8 μg HA + AF03; 12-35 months 7.5 μg HA; 12-35 months
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 48 (6.25%)
    4 / 50 (8.00%)
    3 / 52 (5.77%)
    3 / 51 (5.88%)
    1 / 48 (2.08%)
    1 / 50 (2.00%)
    1 / 52 (1.92%)
    2 / 50 (4.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Traumatic brain injury
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Duchenne muscular dystrophy
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 48 (2.08%)
    1 / 50 (2.00%)
    0 / 52 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 50 (2.00%)
    1 / 52 (1.92%)
    1 / 51 (1.96%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oral herpes
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 50 (2.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 50 (2.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchitis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 50 (2.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    1.9 μg HA + ½ AF03; 6-11 months 3.8 μg HA + ½ AF03; 6-11 months 3.8 μg HA + AF03; 6-11 months 7.5 μg HA; 6-11 months 1.9 μg HA + ½ AF03; 12-35 months 3.8 μg HA + ½ AF03; 12-35 months 3.8 μg HA + AF03; 12-35 months 7.5 μg HA; 12-35 months
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 48 (66.67%)
    28 / 50 (56.00%)
    36 / 52 (69.23%)
    39 / 51 (76.47%)
    28 / 48 (58.33%)
    28 / 50 (56.00%)
    29 / 52 (55.77%)
    19 / 50 (38.00%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 48 (4.17%)
    2 / 50 (4.00%)
    3 / 52 (5.77%)
    5 / 51 (9.80%)
    3 / 48 (6.25%)
    5 / 50 (10.00%)
    4 / 52 (7.69%)
    2 / 50 (4.00%)
         occurrences all number
    2
    2
    3
    5
    3
    5
    4
    2
    Nervous system disorders
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    21 / 48 (43.75%)
    14 / 49 (28.57%)
    27 / 52 (51.92%)
    17 / 51 (33.33%)
    4 / 14 (28.57%)
    4 / 15 (26.67%)
    6 / 15 (40.00%)
    4 / 10 (40.00%)
         occurrences all number
    25
    23
    35
    20
    6
    5
    9
    4
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    3 / 34 (8.82%)
    1 / 35 (2.86%)
    2 / 37 (5.41%)
    2 / 39 (5.13%)
         occurrences all number
    0
    0
    0
    0
    3
    1
    2
    3
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 48 (4.17%)
    4 / 50 (8.00%)
    1 / 52 (1.92%)
    5 / 51 (9.80%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    3
    5
    2
    5
    0
    0
    0
    0
    Injection site tenderness
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    16 / 48 (33.33%)
    12 / 49 (24.49%)
    24 / 52 (46.15%)
    9 / 51 (17.65%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    22
    16
    32
    12
    0
    0
    0
    0
    Injection site erythema
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    12 / 48 (25.00%)
    11 / 50 (22.00%)
    26 / 52 (50.00%)
    9 / 51 (17.65%)
    18 / 48 (37.50%)
    16 / 50 (32.00%)
    28 / 52 (53.85%)
    12 / 49 (24.49%)
         occurrences all number
    14
    14
    29
    12
    23
    19
    36
    14
    Injection site swelling
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    6 / 48 (12.50%)
    4 / 49 (8.16%)
    9 / 52 (17.31%)
    2 / 51 (3.92%)
    7 / 48 (14.58%)
    6 / 50 (12.00%)
    12 / 52 (23.08%)
    7 / 49 (14.29%)
         occurrences all number
    7
    4
    9
    2
    7
    6
    15
    7
    Injection site ecchymosis
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    3 / 48 (6.25%)
    7 / 49 (14.29%)
    7 / 52 (13.46%)
    5 / 51 (9.80%)
    6 / 48 (12.50%)
    14 / 50 (28.00%)
    5 / 52 (9.62%)
    8 / 49 (16.33%)
         occurrences all number
    3
    8
    7
    5
    6
    16
    5
    10
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    17 / 48 (35.42%)
    23 / 50 (46.00%)
    22 / 52 (42.31%)
    7 / 51 (13.73%)
    4 / 14 (28.57%)
    3 / 15 (20.00%)
    4 / 15 (26.67%)
    2 / 10 (20.00%)
         occurrences all number
    19
    26
    26
    9
    5
    3
    6
    2
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    10 / 34 (29.41%)
    3 / 35 (8.57%)
    4 / 37 (10.81%)
    10 / 39 (25.64%)
         occurrences all number
    0
    0
    0
    0
    12
    3
    6
    12
    Shivering
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    6 / 34 (17.65%)
    1 / 35 (2.86%)
    9 / 37 (24.32%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    0
    0
    8
    1
    11
    2
    Psychiatric disorders
    Crying abnormal
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    29 / 48 (60.42%)
    26 / 49 (53.06%)
    30 / 52 (57.69%)
    27 / 51 (52.94%)
    4 / 14 (28.57%)
    7 / 15 (46.67%)
    8 / 15 (53.33%)
    5 / 10 (50.00%)
         occurrences all number
    36
    37
    35
    38
    4
    9
    11
    5
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed [11]
    32 / 48 (66.67%)
    28 / 49 (57.14%)
    36 / 52 (69.23%)
    39 / 51 (76.47%)
    5 / 14 (35.71%)
    9 / 15 (60.00%)
    10 / 15 (66.67%)
    6 / 10 (60.00%)
         occurrences all number
    45
    41
    48
    57
    8
    14
    15
    8
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 48 (8.33%)
    4 / 50 (8.00%)
    7 / 52 (13.46%)
    3 / 51 (5.88%)
    2 / 48 (4.17%)
    3 / 50 (6.00%)
    0 / 52 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    5
    6
    10
    3
    2
    3
    0
    1
    Teething
         subjects affected / exposed
    8 / 48 (16.67%)
    14 / 50 (28.00%)
    8 / 52 (15.38%)
    15 / 51 (29.41%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    12
    19
    8
    19
    0
    0
    0
    0
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed [12]
    16 / 48 (33.33%)
    11 / 49 (22.45%)
    12 / 52 (23.08%)
    7 / 51 (13.73%)
    1 / 14 (7.14%)
    2 / 15 (13.33%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    23
    13
    13
    7
    1
    2
    0
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    3 / 48 (6.25%)
    2 / 50 (4.00%)
    0 / 52 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    0
    0
    0
    3
    2
    0
    2
    Injection site induration
    alternative assessment type: Systematic
         subjects affected / exposed [13]
    12 / 48 (25.00%)
    12 / 49 (24.49%)
    19 / 52 (36.54%)
    9 / 51 (17.65%)
    10 / 48 (20.83%)
    15 / 50 (30.00%)
    10 / 52 (19.23%)
    5 / 49 (10.20%)
         occurrences all number
    14
    15
    20
    10
    12
    18
    13
    7
    Musculoskeletal and connective tissue disorders
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed [14]
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    9 / 34 (26.47%)
    5 / 35 (14.29%)
    9 / 37 (24.32%)
    5 / 39 (12.82%)
         occurrences all number
    0
    0
    0
    0
    10
    6
    13
    7
    Metabolism and nutrition disorders
    Appetite lost
    alternative assessment type: Systematic
         subjects affected / exposed [15]
    23 / 48 (47.92%)
    21 / 49 (42.86%)
    25 / 52 (48.08%)
    25 / 51 (49.02%)
    7 / 14 (50.00%)
    9 / 15 (60.00%)
    11 / 15 (73.33%)
    4 / 10 (40.00%)
         occurrences all number
    30
    28
    30
    30
    9
    12
    16
    5
    Infections and infestations
    Ear infection
         subjects affected / exposed
    4 / 48 (8.33%)
    3 / 50 (6.00%)
    1 / 52 (1.92%)
    2 / 51 (3.92%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    4
    3
    1
    2
    0
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    2 / 48 (4.17%)
    3 / 50 (6.00%)
    1 / 52 (1.92%)
    3 / 51 (5.88%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    2
    3
    1
    3
    0
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    11 / 48 (22.92%)
    6 / 50 (12.00%)
    3 / 52 (5.77%)
    5 / 51 (9.80%)
    3 / 48 (6.25%)
    7 / 50 (14.00%)
    3 / 52 (5.77%)
    6 / 50 (12.00%)
         occurrences all number
    13
    6
    3
    5
    3
    7
    3
    6
    Otitis media
         subjects affected / exposed
    10 / 48 (20.83%)
    5 / 50 (10.00%)
    5 / 52 (9.62%)
    7 / 51 (13.73%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    10
    6
    5
    7
    0
    0
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 48 (2.08%)
    1 / 50 (2.00%)
    3 / 52 (5.77%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    3
    1
    Rhinitis
         subjects affected / exposed
    9 / 48 (18.75%)
    10 / 50 (20.00%)
    12 / 52 (23.08%)
    9 / 51 (17.65%)
    6 / 48 (12.50%)
    9 / 50 (18.00%)
    5 / 52 (9.62%)
    6 / 50 (12.00%)
         occurrences all number
    10
    11
    14
    10
    7
    12
    5
    6
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 48 (14.58%)
    7 / 50 (14.00%)
    10 / 52 (19.23%)
    11 / 51 (21.57%)
    6 / 48 (12.50%)
    4 / 50 (8.00%)
    7 / 52 (13.46%)
    3 / 50 (6.00%)
         occurrences all number
    8
    7
    14
    11
    6
    4
    7
    3
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 {or 3 as applicable} days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 {or 3 as applicable} days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 {or 3 as applicable} days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 {or 3 as applicable} days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 {or 3 as applicable} days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 {or 3 as applicable} days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 {or 3 as applicable} days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 {or 3 as applicable} days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 {or 3 as applicable} days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 {or 3 as applicable} days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 {or 3 as applicable} days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 {or 3 as applicable} days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 {or 3 as applicable} days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 {or 3 as applicable} days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 {or 3 as applicable} days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Sep 2009
    The modalities of physical examination to be performed by investigators were changed.
    01 Feb 2010
    Documented the persistence of anti-HA antibodies in a subset of subjects who received two half-doses of either the 15 μg HA or 3.8 μg HA + AF03 vaccine (i.e. 7.5 μg HA and 1.9 μg HA + ½ AF03 doses, respectively). The subjects included in the antibody persistence evaluation were followed for persistence of the immune response 8 months after the first A/H1N1 vaccination. One more visit (V05) was planned 8 months after the first vaccination to perform blood sampling for the subjects who participated in antibody persistence evaluation.
    30 Jun 2010
    Evaluated the safety and the immune response to the seasonal trivalent seasonal influenza vaccine 2010-2011 NH formulation on the subjects previously vaccinated with two half-doses of the 3.8 μg HA + AF03 or the unadjuvanted 15 μg HA pandemic influenza vaccines. For subjects aged more than 36 months, two visits, Visit 06, planned one year after the first A/H1N1 pandemic influenza vaccine injection and Visit 07, planned 21 days after Visit 06, were added. For subjects aged less than 36 months, three visits, Visit 06, planned one year after the first A/H1N1 pandemic influenza vaccine injection, Visit 07, planned 21 to 28 days after Visit 06 and Visit 08 planned 42 to 45 days after Visit 6 were added.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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